Transplantation of Deceased Donors With COVID-19 Into COVID-19 Negative Recipients Utilizing Casirivimab and Imdevimab Antibody Cocktail

This study will look to increase the donor pool for the solid organ transplant population by transplanting patients who died with COVID-19 but not from COVID-19 utilizing casirivimab and imdevimab antibody cocktail to prevent the transmission of the virus.

Study Overview

• Status: Withdrawn
• Conditions: COVID-19; Organ Transplant
• Intervention / Treatment: Drug: Casirivimab and Imdevimab Antibody Cocktail

Detailed Description

This is single-center, proof of concept study that is expected to last up to three months. The target enrollment for this study is 14 subjects ≥18 years of age with a need of a kidney, liver or heart. This study will investigate the effects of the investigational product during a four-week intervention phase followed by a 12-month observation phase. Study population will be derived from patients in Northwell Health Transplant Center.

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Manhasset, New York, United States, 11030
      • Northwell Health Organ Transplant Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject provides written informed consent prior to initiation of any study procedures.
2. Understands and agrees to comply with planned study procedures.
3. Adult ≥18 years of age at time of enrollment, pediatric ages will be excluded.

4. Subject consents to receiving a COVID-19 positive organ (kidney, liver, or heart)

   a. Deceased immunocompetent donor with positive SARS-CoV-2 RT-PCR testing from the respiratory tract (upper or lower): i. Within 21 days since the date of COVID-19 diagnosis OR ii. Within 90 days since the date of COVID-19 diagnosis

5. Subject is confirmed COVID-19 negative confirmed by PCR at time of transplant with no signs and symptoms consistent with COVID-19
6. All candidates must be fully vaccinated 2 weeks prior to enrollment a. When applicable candidates can receive a booster vaccine as defined by the FDA/CDC

Exclusion Criteria:

1. Any exposure to investigational medications targeting COVID-19
2. Previous use of casirivimab with imdevimab antibody cocktail (REGEN-COV)
3. Previous treatment of COVID-19 with a monoclonal antibody
4. Active COVID-19 infection
5. Allergy to casirivimab with imdevimab
6. Pregnant patients
7. Prior transplant
8. Hepatitis C virus/NCT positive deceased donors

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Casirivimab and Imdevimab Antibody Cocktail; Patients receiving a Covid-19 positive liver, kidney, or heart transplant.	Drug: Casirivimab and Imdevimab Antibody Cocktail; The study will utilize REGEN-COV 8,000mg (4,000 mg of each monoclonal antibody) given as IV infusion on day of transplant and 2400mg (1,200 mg of each monoclonal antibody) on post-operative day 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monitoring for SARS-CoV-2 infection	The overall objective of the study is to have transplant COVID-19 positive organs into COVID-19 negative recipients with no transmission of the virus. This will be assessed by monitoring for SARS-CoV-2 infection at different time points post-transplantation.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day admission rate to hospital post-transplant due to COVID-19	No 30-day readmission to the hospital due to COVID-19. All patients re-admitted to the hospital will be tested for COVID-19 by nasopharyngeal swab	30 days
Patient and graft survival at 30 days, 6 months and 1 year	Assess patient and graft survival at 30 days	30 days, 6 months, and 1 year
Adverse effects of casirivimab with imdevimab (REGEN-COV) antibody cocktail	Assessment of adverse effects of casirivimab with imdevimab	1 year
Stored serum will be evaluated when feasible for SARS-CoV-2 RNA	Biopsy proven rejection at 30 days	30 days

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: Regeneron Pharmaceuticals
• Investigators: Principal Investigator: Lewis Teperman, MD, Northwell Health

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2022
• Primary Completion (ANTICIPATED): January 1, 2024
• Study Completion (ANTICIPATED): January 1, 2025

Study Registration Dates

• First Submitted: December 13, 2021
• First Submitted That Met QC Criteria: December 13, 2021
• First Posted (ACTUAL): December 15, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 14, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Regeneron; Covid-19 Antibodies
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: 21-1223 (INCar Protocol Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No